Prophylactic Anti-Seizure Medication vs No Anti-Seizure Medication for Patients With Primary Motor Cortex Brain Metastases
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Ayal A. Aizer, MD
- Study ID
- NCT07130786
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Brain Metastases From Extra-cranial Solid Tumors
- Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
- Brain Metastases, Adult
- Primary Motor Cortex
- Seizures
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Levetiracetam (Keppra) — DRUGPatients will be randomized to receive levetiracetam/ASM or to receive no ASM therapy
Study Details
This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive prophylactic levetiracetam or not receive prophylactic levetiracetam.
Key Dates
- Start date
- Dec 23, 2025
- Status verified
- Mar 2026
- Primary completion
- Feb 28, 2029
- Completion
- Feb 28, 2030
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Prophylactic LevetiracetamLevetiracetam Anti-Seizure Medication
- No Intervention: No Prophylactic LevetiracetamNo Anti-Seizure Medication
Primary Outcome Measure
Seizure Rate [ Time Frame: Duration of time on study (estimated 1 year) ]
Central Contacts
- Ayal A Aizer, MD, MHS(617) 732-7560
- Ivy B Ricca, BA(617) 582-8927
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 |
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